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Zai Lab Limited (NASDAQ: ZLAB) is a pioneering biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines. Established in 2013 by industry veterans, Zai Lab addresses some of the world's most pressing unmet medical needs with a vision to transform patients’ lives globally.
The company employs a dual approach of in-licensing products and internal research and development to maintain a robust pipeline. This strategy has led to the development of promising drug candidates aimed at treating a range of severe health conditions, particularly in oncology, autoimmune, and infectious diseases.
Core Products and Pipeline:
- ZL-2306: An investigational treatment for multiple solid tumor types, including ovarian, breast, and lung cancers.
- ZL-2401: A novel antibiotic belonging to a new class of tetracycline derivatives, significant in the battle against resistant bacterial infections.
- ZL-2301: An oral small molecule targeting hepatocellular carcinoma (HCC), promising for liver cancer treatment.
Zai Lab's leadership team is acclaimed for their innovative regulatory approval pathways in China, which have expedited the introduction of new therapies. The company's partnerships with global pharmaceutical giants underscore its commitment to conducting world-class clinical development both in China and internationally.
Financially, Zai Lab has strong support from a cadre of leading healthcare investors, ensuring robust backing for its ambitious projects. This financial stability allows the company to explore cutting-edge research and expand its therapeutic offerings continually.
Recent Achievements and Current Projects:
- Successful initiation of multiple late-stage clinical trials across various therapeutic areas.
- Establishment of strategic partnerships with multinational pharmaceutical companies to enhance drug development and commercialization.
- Ongoing expansion of their research facilities to accommodate new projects and collaborations.
Zai Lab remains committed to leveraging its expertise, innovation, and strategic partnerships to bring life-changing therapies to market, ultimately improving patient outcomes worldwide.
Zai Lab announced positive results from the Phase 3 ADVANCE trial of VYVGART for chronic immune thrombocytopenia (ITP). The trial met its primary endpoint, showing 21.8% of patients on VYVGART achieved a sustained platelet response, compared to 5% on placebo (p=0.0316). Significant benefits were also observed in key secondary endpoints related to platelet counts. VYVGART maintained a consistent safety profile. With 131 patients enrolled, this trial positions VYVGART as a promising treatment option for ITP, with topline data from the subsequent ADVANCE-SC trial expected in Q1 2023.
Zai Lab (NASDAQ: ZLAB) and Turning Point Therapeutics announced encouraging topline results from the Phase 1/2 TRIDENT-1 study of repotrectinib in China. The study demonstrated a 91% confirmed objective response rate (cORR) in the TKI-naïve cohort, with a duration of response (DOR) follow-up of 3.7 months. In three TKI-pretreated cohorts, cORR ranged from 36%-67%. Zai Lab plans to discuss these results with Chinese health authorities in Q4 2022, aiming to advance their regulatory pathway. The TRIDENT-1 study continues to enroll patients globally.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has engaged KPMG as its independent registered public accounting firm to facilitate compliance with U.S. audit requirements under the Holding Foreign Companies Accountable Act. This strategic move aims to ensure the company's continued listing on Nasdaq. The engagement of KPMG, based in the United States, will cover annual consolidated financial statements and internal controls over financial reporting for the fiscal year ending December 31, 2022. The transition was amicable, with no unresolved issues with the previous auditor.
Zai Lab Limited (NASDAQ: ZLAB) has announced it will report its financial results for Q1 2022 on May 10, 2022, following market close. The company will host a conference call and webcast on May 11, 2022, at 8:00 a.m. ET. Zai Lab is focused on developing therapies for unmet medical needs in oncology, autoimmune disorders, infectious diseases, and neuroscience. It aims to become a leading global biopharmaceutical company through innovative product development and strategic partnerships.
Zai Lab Limited (NASDAQ: ZLAB) is set to present groundbreaking data on its oncology pipeline at the 2022 AACR Annual Meeting in New Orleans from April 8-13, 2022. Key highlights include the first preview of preclinical data for ZL-1218, an anti-CCR8 antibody targeting solid tumors, along with additional candidates like ZL-1201 and ZL-1211 for various cancers. The oral presentation will take place on April 12, 2022, showcasing promising therapeutic developments. Zai Lab emphasizes its commitment to advancing cancer treatments globally, addressing significant unmet medical needs.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced an extraordinary general meeting (EGM) to be held virtually on March 28, 2022, at 8:00 a.m. Eastern Time. This change is due to COVID-19 restrictions in Shanghai. Shareholders will vote on a proposal for a 1-to-10 share subdivision. Shareholders of record may attend the meeting virtually using a control number found on their proxy materials. The EGM format has been updated, but prior proxy materials remain valid for voting.
Zai Lab Limited (NASDAQ: ZLAB) presented Phase 3 PRIME study results at the Society of Gynecologic Oncology annual meeting, revealing that ZEJULA (niraparib) significantly improved progression-free survival (PFS) in patients with advanced ovarian cancer. The median PFS for niraparib was 24.8 months compared to 8.3 months for placebo. Treatment was well-tolerated, with a low discontinuation rate due to adverse events (less than 7%). This data supports niraparib as a standard maintenance therapy after platinum-based chemotherapy in China.
Zai Lab Limited (NASDAQ: ZLAB) announced the appointment of Josh Smiley as Chief Operating Officer (COO) effective August 1, 2022. With over 26 years of biopharmaceutical experience, he previously held leadership roles at Eli Lilly. CEO Dr. Samantha Du emphasized Smiley's leadership expertise as essential for Zai Lab's growth and operational excellence. His appointment comes during a pivotal time for Zai Lab, with significant opportunities in their pipeline aimed at expanding geographically and diversifying their financial base.
Zai Lab Limited (NASDAQ: ZLAB) reported strong financial growth for 2021, achieving net product revenues of $144.1 million compared to $49.0 million in 2020. Key drivers included a 200% increase in ZEJULA revenue and significant advancements in its product pipeline, including proof of concept for ZL-1102. R&D expenses increased to $573.3 million due to new licensing agreements and clinical trials. The company plans to submit new drug applications and expects substantial revenue growth, projecting peak-year sales of $2.5 to $3 billion by 2030.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced that its investigational drug repotrectinib received Breakthrough Therapy Designation from the NMPA for treating ROS1-positive metastatic non-small-cell lung cancer (NSCLC) in patients who haven't received ROS1 TKI treatment. The Phase 1/2 TRIDENT-1 study provided initial data supporting this designation. Repotrectinib targets ROS1 and NTRK mutations and may be the best-in-class therapy, offering hope for patients in need, especially in a region with high lung cancer incidence.
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